SARNS HIGH FLOW AORTIC ARCH CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

GORE BIO-A FISTULA PLUG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BD VIPER SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053

FDA 510(k)

FDA Class 2 ·Neurology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

JMS APHERESIS NEEDLE SET WINGEATER(R) V2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

BALLOON TEMP. PACING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLIRANS TAF HOLLOW FIBER DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDICAM LAPAROSCOPY ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BBL CRYSTAL MRSA ID SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS

FDA 510(k)

FDA Class 2 ·Hematology

XPress BCD Breast Compression Device

FDA 510(k)

FDA Class 2 ·Radiology

CAPIOX HARDSHELL VENOUS RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAEDA NEW NEEDLE DISPOSABLE

FDA 510(k)

FDA Class 2 ·General Hospital

SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS

FDA 510(k)

FDA Class 2 ·Microbiology

STRETCHER, WHEELED, MECHANICAL

FDA 510(k)

FDA Class 2 ·General Hospital

ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM

FDA 510(k)

FDA Class 2 ·Dental